A Prospective, Long-term Analysis of Clinical Outcomes in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Tremor

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The goal of this observational study is to evaluate the long-term efficacy and safety of MR-guided focused ultrasound (MRgFUS) thalamotomy in patients with medication-refractory essential tremor. The main questions it aims to answer are: 1. Does MRgFUS thalamotomy provide sustained reduction in tremor severity over 3 years? 2. What are the long-term neurological and quality-of-life outcomes associated with this procedure? Participants will: * Undergo MRgFUS thalamotomy as part of standard of care at Sunnybrook Health Sciences Centre. * Be followed prospectively for a minimum of 3 years with scheduled assessments including: 1. Clinical Rating Scale for Tremor (CRST) 2. Neurological exams and adverse event monitoring 3. Quality of Life in Essential Tremor (QUEST) questionnaire 4. Scale for the Assessment and Rating of Ataxia (SARA) 5. MRI imaging and neuropsychological testing

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• Aged 22 years or older

• Able and willing to give consent and to attend all visits

• Diagnosed with essential tremor that is refractory to at least two first-line tremor medications

• Confirmed to have moderate-to-severe hand tremor by the MRI guided Focused Ultrasound (MRgFUS) neurology team

• Deemed suitable surgical candidates (decision-to-treat) by the MRgFUS neurosurgical team

Locations
Other Locations
Canada
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Nir Lipsman, MD, PhD, FRCSC
Nir.Lipsman@sunnybrook.ca
416-480-6954
Backup
Nadia Scantlebury, PhD
Nadia.Scantlebury@sunnybrook.ca
416- 480-6100
Time Frame
Start Date: 2025-10
Estimated Completion Date: 2032-09
Participants
Target number of participants: 240
Treatments
Cohort 1: Magnetic Resonance-Guided Focused Ultrasound (MRgFUS) Thalamotomy
Patients with medication-refractory essential tremor who are scheduled to undergo MRgFUS thalamotomy at Sunnybrook Health Sciences Centre as part of standard of care. Eligible participants providing informed consent will be enrolled and followed prospectively for a minimum of 3 years to evaluate long-term efficacy and safety outcomes.
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov

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